Table S2.

Additional patient-reported outcome endpoints (ITT population, unless stated otherwise)

	GFF MDI 18/9.6 μg	GP MDI 18 μg	FF MDI 9.6 μg	Placebo MDI
TDI focal score at Week 24
n	487	410	413	196
LSM	1.8	1.4	1.6	0.9
SE	0.12	0.13	0.13	0.19
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	0.41 (0.06, 0.75)	0.20 (−0.15, 0.55)	0.90 (0.46, 1.34)
P-value	NA	0.0229	0.2659	<0.0001
TDI focal score at Week 24 (symptomatic population)a
n	219	201	188	91
LSM	1.7	1.1	1.6	0.8
SE	0.19	0.20	0.20	0.29
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	0.63 (0.10, 1.17)	0.11 (−0.43, 0.66)	0.87 (0.19, 1.55)
P-value	NA	0.0202	0.6879	0.0122
Change from baseline in SGRQ total score over 12–24 weeksb
n	516	436	436	205
LSM	−5.2	−3.6	−5.0	−1.7
SE	0.46	0.50	0.50	0.72
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	−1.62 (−2.94, −0.30)	−0.27 (−1.59, 1.05)	−3.50 (−5.18, −1.82)
P-value	NA	0.0165	0.6908	<0.0001
Change from baseline in SGRQ total score over 12–24 weeksb(symptomatic population)a
n	237	218	200	97
LSM	−6.9	−3.9	−7.3	−3.1
SE	0.76	0.79	0.83	1.19
Treatment difference for GFF MDI vs monocomponents and placebo MDI
LSM (95% CI)	NA	−2.99 (−5.15, −0.84)	0.32 (−1.89, 2.53)	−3.83 (−6.60, −1.06)
P-value	NA	0.0066	0.7787	0.0068

Notes:

^aThe symptomatic population was defined as patients in the ITT population with a COPD assessment test score ≥15 at baseline (screening).

^bSGRQ score over 12–24 weeks was based on assessments at Weeks 12, 16, 20, and 24.

Abbreviations: FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; ITT, intent to treat; LSM, least squares mean; MDI, metered dose inhaler; NA, not applicable; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index.